Role of Postoperative Radiotherapy in T1-T2N0M0 Glottic Carcinoma Involving the Anterior Commissure
20 de agosto de 2026 actualizado por: Second Affiliated Hospital, Zhejiang University, School of Medicine
Role of Postoperative Radiotherapy in T1-T2N0M0 Glottic Carcinoma Involving the Anterior Commissure: A Prospective, Multicenter, Phase II Clinical Trial
There remains no uniform treatment modality for glottic laryngeal carcinoma.
Current clinical guidelines broadly recommend surgery or radiotherapy as single modality treatment for early stage glottic laryngeal carcinoma.
Glottic carcinoma with anterior commissure invasion is linked to inferior local control; both definitive radiotherapy alone or transoral laser microsurgery (TLM) may confer a higher risk of local recurrence compared with other glottic carcinomas.
We hypothesize that postoperative radiotherapy can act as an effective adjunct to surgery and reduce recurrence rates in patients with glottic carcinoma involving the anterior commissure.
This study aims to conduct a multicenter, prospective, single arm phase II clinical trial of intensity modulated radiotherapy (IMRT) for postoperative patients with early stage glottic laryngeal carcinoma and anterior commissure involvement, to preliminarily evaluate the effect of IMRT on local control rates and long term survival outcomes in this patient population.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
38
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Dongjun Dai, Doctor
- Número de teléfono: 86-0571-86992821
- Correo electrónico: daidongjunmed@zju.edu.cn
Ubicaciones de estudio
-
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310009
- Reclutamiento
- Second Affiliated Hospital of Zhejiang University School of Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Aged 18 years or older, regardless of gender;
- Pathologically confirmed glottic squamous cell carcinoma;
- T1-T2N0M0 glottic laryngeal carcinoma with anterior commissure involvement;
- Patients who have undergone curative intent surgery for glottic carcinoma with negative surgical margins, within 4-8 weeks post operation;
- No prior radiotherapy, chemotherapy or other anti neoplastic agent treatment;
- ECOG performance status of 0 or 1;
- Signed informed consent form.
Exclusion Criteria:
- Patients without anterior commissure involvement;
- Prior chemotherapy or treatment with other anti neoplastic agents;
- Prior history of head and neck radiotherapy;
- Prior participation in other clinical trials;
- Patients with severe allergy history or allergic diathesis, e.g., contrast medium allergy;
- Pregnant or lactating women;
- Patients with uncontrolled acute infection;
- Patients with drug addiction, substance abuse, chronic heavy alcohol consumption, or human immunodeficiency virus (HIV) infection;
- Patients with other uncontrolled concurrent malignancies.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Postoperative radiotherapy
intensity modulated radiotherapy (IMRT)
|
Postoperative radiotherapy clinical target volume (CTV) design: The conventional postoperative laryngeal radiotherapy target is defined as CTV1, which encompasses the entire laryngeal structure, piriform sinus, gloss-epiglottic vallecula, paraglottic space, pre-epiglottic space, thyroid cartilage, and extends to the inferior border of the cricoid cartilage. For T2 tumours, CTV2 is delineated to include bilateral cervical lymph node regions II-III. PTV1 and PTV2 are defined as the regions expanded by 3 mm outward from CTV1 and CTV2, respectively. The prescribed dose for PTV1 is 60 Gy in 30 fractions (60 Gy/30F), and the prescribed dose for PTV2 is 54 Gy in 30 fractions (54 Gy/30F). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
3-year local-regional failure-free survival (LRFS)
Periodo de tiempo: From the date of surgery to the date of local recurrence, , assessed up to 3 year.
|
3-year local-regional failure-free survival (LRFS): defined as the time from the date of surgery to recurrence of the primary lesion and perilesional tissues.
The index date for recurrence is the date when a measurable new lesion is first identified.
For patients who die of any other cause prior to documented disease recurrence, LRFS is calculated from the date of surgery to the date of death.
For patients without documented disease recurrence or death at the time of analysis (i.e., recurrence-free survivors), the time of the last efficacy assessment will be used as the endpoint.
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From the date of surgery to the date of local recurrence, , assessed up to 3 year.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Adverse events
Periodo de tiempo: From enrollment to the end of treatment at 5 years.
|
The incidence, type, and severity of adverse events (AEs), serious AEs, and immune-related AEs (irAEs) were assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0).
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From enrollment to the end of treatment at 5 years.
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5-year local-regional failure-free survival (LRFS)
Periodo de tiempo: From the date of surgery to the date of local recurrence, assessed up to 5 year.
|
5-year local-regional failure-free survival (LRFS): defined as the time from the date of surgery to recurrence of the primary lesion and perilesional tissues.
The index date for recurrence is the date when a measurable new lesion is first identified.
For patients who die of any other cause prior to documented disease recurrence, LRFS is calculated from the date of surgery to the date of death.
For patients without documented disease recurrence or death at the time of analysis (i.e., recurrence-free survivors), the time of the last efficacy assessment will be used as the endpoint.
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From the date of surgery to the date of local recurrence, assessed up to 5 year.
|
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5-year overall survival (OS)
Periodo de tiempo: From the date of surgery until the date of surgery due to any cause, assessed up to 5 year.
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Overall Survival(OS) is defined as the period from the date of surgery to the date of death due to any cause.
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From the date of surgery until the date of surgery due to any cause, assessed up to 5 year.
|
|
5-year disease-free survival (DFS)
Periodo de tiempo: Time from the date of surgery to any evidence of tumour growth or death, assessed up to 5 year.
|
5-year disease-free survival (DFS): defined as the time from the date of surgery during which the patient remains alive without evidence of tumour growth.
Recurrence is defined as the emergence of new lesions, including recurrence of the primary lesion and perilesional tissues, cervical lymph-node metastasis, and distant metastasis.
The index date for recurrence is the date on which a measurable new lesion is first identified.
For patients who die of any other cause prior to documented disease recurrence, DFS is calculated from the date of surgery to the date of death.
For patients with no documented disease recurrence or death at the time of analysis (i.e., disease-free survivors), the time of the last efficacy assessment will serve as the endpoint.
|
Time from the date of surgery to any evidence of tumour growth or death, assessed up to 5 year.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
16 de septiembre de 2026
Finalización primaria (Estimado)
31 de diciembre de 2031
Finalización del estudio (Estimado)
31 de diciembre de 2031
Fechas de registro del estudio
Enviado por primera vez
18 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2026
Publicado por primera vez (Actual)
24 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-0861
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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